FMF · Class II · 21 CFR 880.5860

FDA Product Code FMF: Syringe, Piston

Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.

These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.

FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Sherwood Medical Co. and Becton, Dickinson and Company.

753
Total
753
Cleared
124d
Avg days
1976
Since
753 devices
265–288 of 753
Cleared Nov 06, 1981
MONOJECT PREFILLED SYRINGES
K812934
Sherwood Medical Co.
General Hospital · 17d
Cleared Oct 23, 1981
MONOJECT M535 35CC SYRINGE
K812748
Sherwood Medical Co.
General Hospital · 24d
Cleared Jul 28, 1981
MONOJECT STERILE M506 6CC SYRINGES
K812023
Sherwood Medical Co.
General Hospital · 8d
Cleared Jun 18, 1981
MONOJECT STERILE M503 3CC SYRINGES
K811505
Sherwood Medical Co.
General Hospital · 22d
Cleared Jun 12, 1981
PREFILLED PULSATOR SYRINGE
K811009
Concord Laboratories, Inc.
General Hospital · 58d
Cleared May 21, 1981
PREFILLED PULSATOR SYRINGE
K810995
Concord Laboratories, Inc.
General Hospital · 38d
Cleared May 05, 1981
PISTON SYRINGE
K811065
Sherwood Medical Co.
General Hospital · 18d
Cleared Jul 08, 1980
CONTROL SYRINGE
K801430
Abco Dealers, Inc.
General Hospital · 21d
Cleared Jun 17, 1980
BURRON MULTI-AD SYRINGE CAP
K801311
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Nov 16, 1979
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033
Medline Industries, Inc.
General Hospital · 37d
Cleared Dec 12, 1978
PUNCTURE KIT, DISPOSALBE VEIN
K781978
Arrow Intl., Inc.
General Hospital · 15d
Cleared Apr 19, 1978
MINI-IRRIGATION TRAY
K780595
Abco Dealers, Inc.
General Hospital · 9d
Cleared Apr 19, 1978
IRRIGATION TRAY
K780600
Abco Dealers, Inc.
General Hospital · 9d
Cleared Apr 19, 1978
SYRINGE (IRRIGATION)
K780602
Abco Dealers, Inc.
General Hospital · 9d
Cleared Jan 26, 1978
SYRINGE, BLOOD, SAMPLING, ARTERIAL
K772338
C.R. Bard, Inc.
Hematology · 35d
Cleared Oct 21, 1977
SYRINGE, DISPOSABLE
K771888
Orthopedic Equipment Co., Inc.
General Hospital · 16d
Cleared Sep 13, 1977
ARTEOIAL BLOOD SAMPLING KIT 2D9014
K771584
Travenol Laboratories, S.A.
General Hospital · 26d
Cleared Jul 15, 1977
TRAY, BLOOD GAS, ARTERIAL, #4014
K770850
Concord Laboratories, Inc.
General Hospital · 67d
Cleared Jul 14, 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
K770851
Concord Laboratories, Inc.
General Hospital · 66d
Cleared Jul 14, 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015
K770852
Concord Laboratories, Inc.
General Hospital · 66d
Cleared Apr 05, 1977
OVERDOSE KIT
K770238
American Hospital Supply Corp.
Toxicology · 57d
Cleared Apr 05, 1977
TRAY, BLOOD GAS, CAT. NO. 4010
K770361
Concord Laboratories, Inc.
General Hospital · 42d